Lapidus screw guide assembly and method of insertion

ABSTRACT

A screw guide assembly includes a guide body extending along a central longitudinal axis. The guide body has a proximal end portion having an attachment face extending perpendicular to the longitudinal axis and a distal end portion having a screw support member extending away from the longitudinal axis. The screw support member is configured to allow for the insertion of a screw at an angle oblique relative to the longitudinal axis. A wire guide is removably inserted into the screw support member. A method of inserting a screw using the assembly is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of co-pending application Ser.No. 16/201,144, filed on Nov. 27, 2018, which is a continuation-in-partof application Ser. No. 15/646,497, filed on Jul. 11, 2017 and issued onAug. 20, 2019 as U.S. Pat. No. 10,383,737, which is acontinuation-in-part of application Ser. No. 15/213,935, filed on Jul.19, 2016 and issued on Aug. 28, 2018 as U.S. Pat. No. 10,058,431, whichis a continuation-in-art of application Ser. No. 15/162,657, filed onMay 24, 2016 and issued on Aug. 6, 2019 as U.S. Pat. No. 10,369,251,which is a continuation-in-part of application Ser. No. 14/948,322,filed on Nov. 22, 2015 and issued on Feb. 12, 2019 as U.S. Pat. No.10,201,433, which is a continuation-in-part of co-pending applicationSer. No. 14/513,300, filed on Oct. 14, 2014, which is acontinuation-in-part application of U.S. patent application Ser. No.14/054,100, filed on Oct. 15, 2013 and issued on Jul. 12, 2016 as U.S.Pat. No. 9,387,087, which claims priority from U.S. Provisional PatentApplication Ser. No. 61/715,891, filed on Oct. 19, 2012, all of whichare incorporated by reference herein in their entireties.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to an assembly and a method for aligningand inserting a screw into two bone portions to provide alignment andcompression.

Description of the Related Art

Due to their weight bearing nature, foot bones are subject to severestresses and strains as well as diseases, such as arthritis, throughouta person's life. These issues can result in bone deformities. WhileEvans and Cotton osteotomies are well recognized procedures to correctsome of these deformities, these procedures do not allow the metatarsalto be re-aligned or rotated if the metatarsal has moved or rotated outof alignment. It would be beneficial to provide a device and a methodfor implanting an osteotomy implant while being able to rotate themetatarsal to a proper position.

SUMMARY OF THE INVENTION

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

In one embodiment, the present invention is a screw guide assembly. Theassembly includes a guide body extending along a central longitudinalaxis. The guide body has a proximal end portion having an attachmentface extending perpendicular to the longitudinal axis and a distal endportion having a screw support member extending away from thelongitudinal axis. The screw support member is configured to allow forthe insertion of a screw at an angle oblique relative to thelongitudinal axis. A wire guide is removably inserted into the screwsupport member.

In another embodiment, the invention provides a screw guide assemblycomprising an elongate body having a proximal end portion adapted toreleasably connect to an implant and a distal end portion, distal fromthe proximal end portion. An outrigger extends from the distal endportion and a wire guide is removably inserted into the outrigger.

In still another embodiment, the present invention provides a screwguide assembly comprising a generally planar body having a proximal endportion adapted to releasably engage an implant and a distal end portionhaving at least one arm extending away therefrom. An outrigger isattached to the at least one arm. The outrigger has a through-openingadapted to guide a screw. A wire guide removably inserted into thethrough-opening.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate the presently preferredembodiments of the invention, and, together with the general descriptiongiven above and the detailed description given below, serve to explainthe features of the invention. In the drawings:

FIG. 1 is a side elevational view of a screw guide assembly according tothe present invention attached to a foot bone for screw insertion;

FIG. 2 is a top plan view of the assembly and foot of FIG. 1;

FIG. 3 is a side elevational view of a screw guide used with the screwguide assembly of FIG. 1;

FIG. 4 is a top plan view of the screw guide of FIG. 3;

FIG. 5 is a proximal end view of the screw guide of FIG. 3;

FIG. 6 is a proximal perspective view of the screw guide of FIG. 3;

FIG. 7 is a distal perspective view of the screw guide of FIG. 3;

FIG. 8 is a handle for use with the screw guide of FIG. 3;

FIG. 9 is a side elevational view of a wire guide for use with the screwguide of FIG. 3;

FIG. 10 is a distal perspective view of the screw guide assembly of FIG.1 attached to an implant.

FIG. 11 is a proximal end view of the screw guide assembly with implantof FIG. 10;

FIG. 12 is a distal end view of the screw guide assembly with implant ofFIG. 10;

FIG. 13 is a side elevational view of a foot bone with an osteotomy;

FIG. 14 is an enlarged view of the osteotomy site taken along circle 14of FIG. 13;

FIG. 15 is a perspective view of a trial head being inserted into theosteotomy site of FIG. 13;

FIG. 16 is a proximal elevation view of the trial head of FIG. 15;

FIG. 17 is a perspective view of an implant being inserted into theosteotomy site;

FIG. 18 is a proximal elevational view of the implant of FIG. 17;

FIG. 19 is a side elevational view of the screw guide assembly of FIG. 3with the implant of FIG. 18 inserted into the first metatarsal andstabilizing K-wires inserted through the central portion of the screwguide assembly and into a metatarsal;

FIG. 20 is a perspective view of the screw guide assembly withstabilizing K-wires being used to rotate the metatarsal relative to therest of the foot;

FIG. 21 is a side elevational view of the screw guide assembly with thewire guide inserted into the outrigger;

FIG. 22 is a side elevational view of a K-wire being inserted into thewire guide;

FIG. 23 is a side elevational view of a drill being inserted over theK-wire with the screw wire guide having been removed;

FIG. 24 is a side elevational view of the screw guide assembly havingbeen removed and a countersink drill slid over the K-wire;

FIG. 25 is a side elevational view of a screw being slid over theK-wire;

FIG. 26 is a side elevational view of a driver used to screw the screwinto the bones;

FIG. 27 is a side elevational view of the screw inserted into the firstmetatarsal and the cuneiform, with the screw guide assembly having beenremoved from the implant; and

FIG. 28 is a perspective view of a plate having been connected to themetatarsal and the cuneiform to retain the implant in place.

DETAILED DESCRIPTION

In the drawings, like numerals indicate like elements throughout.Certain terminology is used herein for convenience only and is not to betaken as a limitation on the present invention. The terminology includesthe words specifically mentioned, derivatives thereof and words ofsimilar import. As used herein, the term “proximal” is defined as alocation closer to the heel of the patient into whom an implant is beinginserted and the term “distal” is defined as a location farther from theheel of the patient into whom an implant is being inserted.

The embodiments illustrated below are not intended to be exhaustive orto limit the invention to the precise form disclosed. These embodimentsare chosen and described to best explain the principle of the inventionand its application and practical use and to enable others skilled inthe art to best utilize the invention.

Reference herein to “one embodiment” or “an embodiment” means that aparticular feature, structure, or characteristic described in connectionwith the embodiment can be included in at least one embodiment of theinvention. The appearances of the phrase “in one embodiment” in variousplaces in the specification are not necessarily all referring to thesame embodiment, nor are separate or alternative embodiments necessarilymutually exclusive of other embodiments. The same applies to the term“implementation.”

As used in this application, the word “exemplary” is used herein to meanserving as an example, instance, or illustration. Any aspect or designdescribed herein as “exemplary” is not necessarily to be construed aspreferred or advantageous over other aspects or designs. Rather, use ofthe word exemplary is intended to present concepts in a concretefashion.

Additionally, the term “or” is intended to mean an inclusive “or” ratherthan an exclusive “or”. That is, unless specified otherwise, or clearfrom context, “X employs A or B” is intended to mean any of the naturalinclusive permutations. That is, if X employs A; X employs B; or Xemploys both A and B, then “X employs A or B” is satisfied under any ofthe foregoing instances. In addition, the articles “a” and “an” as usedin this application and the appended claims should generally beconstrued to mean “one or more” unless specified otherwise or clear fromcontext to be directed to a singular form.

Unless explicitly stated otherwise, each numerical value and rangeshould be interpreted as being approximate as if the word “about” or“approximately” preceded the value of the value or range.

The use of figure numbers and/or figure reference labels in the claimsis intended to identify one or more possible embodiments of the claimedsubject matter in order to facilitate the interpretation of the claims.Such use is not to be construed as necessarily limiting the scope ofthose claims to the embodiments shown in the corresponding figures.

It should be understood that the steps of the exemplary methods setforth herein are not necessarily required to be performed in the orderdescribed, and the order of the steps of such methods should beunderstood to be merely exemplary. Likewise, additional steps may beincluded in such methods, and certain steps may be omitted or combined,in methods consistent with various embodiments of the present invention.

Although the elements in the following method claims, if any, arerecited in a particular sequence with corresponding labeling, unless theclaim recitations otherwise imply a particular sequence for implementingsome or all of those elements, those elements are not necessarilyintended to be limited to being implemented in that particular sequence.

In accordance with an exemplary embodiment of the present invention, animplant device with an inner lumen is inserted into a patient's jointbetween the first metatarsal and the cuneiform to restore length and toprovide correction in the medial to lateral direction as well as thedorsal to plantar direction. The implant is connected to an outriggersystem that releasably connects to the implant. The inventive assemblyallows a clinician to properly insert a screw through the firstmetatarsal, through the lumen of the implant, and into the cuneiform,providing compression across the joint.

Referring to FIGS. 1 and 2, a Lapidus screw guide assembly 100(“assembly 100”) according to an exemplary embodiment of the presentinvention is shown, attached to an implant 50 that is inserted between afirst metatarsal 60 and a cuneiform 62 of a foot 63 (only the bones offoot 63 are shown for clarity). Assembly 100 is used to align a screw 70for insertion into the first metatarsal 60, through a lumen in implant50, and into the cuneiform 62.

Referring to FIGS. 3-7, assembly 100 includes a generally planarelongate guide body 102 extending along a central longitudinal axis 104.Guide body 102 has a proximal end portion 106 and a distal end portion108, distal from proximal end portion 106. Body 102 has a centralportion 110 that extends between proximal end portion 106 and distal endportion 108. Body 102 also includes an inferior face 112 and a superiorface 114 opposite inferior face 112.

Proximal end portion 106 has an attachment face 116 extending downwardlyfrom inferior face 112 and perpendicular to the longitudinal axis 104that is adapted to releasably engage and connect to implant 50 (shown inFIG. 10). Attachment face 116 includes a pair of extensions 118 thatserve to extend into a slot (not shown) in implant 50 to preventrotation of implant 50 with respect to attachment face 116. A generallycircular through-opening 119 extends through proximal end portion 106,through attachment face 116, and between extensions 118. A threadedopening 121 is formed in proximal end portion 106 and allows for theinsertion of a ball plunger (not shown) therein.

A handle 120, shown in detail in FIG. 8, is rotatably attached toproximal end portion 106. Handle 120 includes a textured knob 122connected to an unthreaded shaft 124, with a threaded portion 126extending from shaft 124. FIGS. 1 and 2 show handle 120 extendingupwardly from proximal end portion 106.

Shaft 124 has a diameter slightly smaller than the diameter ofthrough-opening 119 and a length slightly longer than the sum of thethickness of proximal end portion 106 and the length of attachment face116 so that, when shaft 124 is inserted through proximal end portion 106and attachment face 116 so that handle 120 extends co-linearly withattachment face 116, threaded portion 126 extends outwardly fromattachment face 116 for threaded engagement with implant 50. A narrowedshaft portion 125 adjacent to handle 122 allows for the ball plungerdescribed above to engage narrowed shaft portion 125 and retain handle120 within through-opening 119 while using assembly 100.

Central portion 110 has at least one through-opening 130 extendingtherethrough from superior face 114 to inferior face 112. As shown inFIG. 4, two through-openings 130 are provide along longitudinal axis104. Additionally, two additional through-openings 132 are providedco-linearly along an axis parallel to longitudinal axis 104.Through-openings 130 have a larger diameter than through-openings 132 toallow K-wires 80 (shown in FIGS. 1, 2, 20, and 21) having differentdiameters to be inserted therein with minimal gap between the K-wire 80and the respective through-openings 130, 132. In an exemplaryembodiment, through-openings 130 have a diameter of 2.4 millimeters andthrough-openings 132 have a diameter of 1.6 millimeters.

Distal end portion 108 has a screw support member 140 that extends awayfrom longitudinal axis 104. Screw support member 140 is configured toallow for the insertion of screw 70 at an angle oblique relative tolongitudinal axis 104. Screw support member 140 is supported by anoutrigger 142 extending from distal end portion 108. Outrigger 142 has afirst arm 144 extending from distal end portion 108 and a second arm 146disposed proximally of first arm 144 such that first and second arms144, 146 are each connected to screw support member 140. Referring toFIG. 4, first arm 144 has a first portion 148 extending obliquely fromdistal end portion 108 and a second portion 150 extending generallyorthogonally to distal end portion 108.

Outrigger 142 includes a screw through-opening 152 extendingtherethrough such that screw through-opening 152 extends obliquely tolongitudinal axis 104. Screw through-opening 152 extends at an anglebetween about 20 degrees and about 30 degrees relative to body 102 andis adapted to guide screw 70 therethrough.

A wire guide 160, shown in detail in FIG. 9, can be removably insertedinto screw through-opening 152, as shown in FIG. 11. Wire guide 160 isused to guide a K-wire 82 (shown in FIGS. 1, 22, and 23) therethrough toassist in inserting screw 70.

Wire guide 160 has a generally cylindrical, elongate body 162 with ahead 164 having a diameter larger than the diameter of screwthrough-opening 152 so that head 164 prevents wire guide 160 fromsliding all the way through screw through-opening 152. Wire guide 160has a narrow bottom end to provide stability to the bone that wire guide160 is intended to contact. Additionally, a plurality of teeth 167 arecut into bottom end 166 to provide an engagement surface for to bone. AK-wire passage 168 extends longitudinally through wire guide 160 fromhead 164 to bottom end 166 to allow K-wire 82 to be insertedtherethrough.

In an exemplary embodiment, body 102, attachment face 116, and wireguide 160 can be constructed from stainless steel, although thoseskilled in the art will recognize that these members can be constructedfrom other, rigid materials such as, for example, a rigid polymer.Assembly 100 with implant 50 attached to attachment face 116 is shown inFIGS. 10-12.

FIGS. 13-28 show graphical illustrations of an exemplary method to useassembly 100 to insert an implant. First, as shown in FIGS. 13 and 14,fusion cuts 64, 66 are made parallel to the first tarsometatarsal(“TMT”) joint if implant 50 is an angled wedge. If a parallel sidedimplant is used, the fusion cut sites should be angled for desiredcorrection.

Next, as shown in FIGS. 15 and 16, trial heads 68 are attached to aninserter 72 and test inserted into the space formed between fusion cuts64, 66 until a desired size/shape implant 50 is located. Exemplaryimplants can be found in U.S. patent application Ser. No. 15/646,497,which is owned by the owner of the present application. As shown inFIGS. 17 and 18, once a desired implant 50 is selected, implant 50 isattached to inserter 72 and inserted into the space between fusion cutsites 64, 66. FIG. 18 shows implant 50 having a lumen 51 formed therein.

As shown in FIG. 19, assembly 100 is attached to implant 50. Assembly100 is attached by inserting threaded end 126 of handle 120 throughdistal end portion 108 and attachment face 116 so that threaded end 126can thread into implant 50. K-wires 80 are inserted throughthrough-openings 130 and into first metatarsal 60. FIG. 20 show theability to rotate first metatarsal 60 relative to cuneiform 62 by usinghandle 120 as a lever to rotate assembly 100 and K-wires 80.

As shown in FIG. 21, wire guide 160 is next removably inserted intoscrew through-opening 152 and, as shown in FIG. 22, a K-wire 82 isinserted through through-opening 168. K-wire 82 extends through firstmetatarsal 60, through lumen 51 in implant 50, and into cuneiform 62.FIG. 23 shows a drill 84 inserted over the distal end of K-wire 82 todrill a passage for the insertion of screw 70.

Optionally, as shown in FIG. 24, assembly 100 can be removed, leavingK-wire 82 in place, and sliding a countersink bit 86 over K-wire 82 todrill a countersink passage. If countersink bit 86 is used, afterward,assembly 100 is reinstalled as shown in FIG. 25, and screw 70 is sildover K-wire 82. FIG. 26 shows a driver 88 slid over K-wire 82 to drivescrew 70 into first metatarsal 60, through lumen 51 in implant 50, andinto cuneiform 62.

After screw 70 is inserted, assembly 100 is removed, as shown in FIG.27. Optionally, as shown in FIG. 28, a plate 90 can be secured to firstmetatarsal 60 and cuneiform 62, over implant 50, to secure implant 50 inplace.

It will be further understood that various changes in the details,materials, and arrangements of the parts which have been described andillustrated in order to explain the nature of this invention may be madeby those skilled in the art without departing from the scope of theinvention as expressed in the following claims.

We claim:
 1. A screw guide assembly comprising: a guide body extendingalong a central longitudinal axis, the guide body having: a proximal endportion; and a distal end portion having an outrigger, the outriggerhaving a screw support member extending away from the longitudinal axis,the screw support member having a through opening configured to allowfor the insertion of a screw at an angle oblique relative to thelongitudinal axis; and the outrigger having a first arm extending from afirst end of the outrigger on a first side of the through opening and asecond arm extending from a second end of the outrigger on a second sideof the through opening, opposite from the first through opening.
 2. Thescrew guide assembly according to claim 1, wherein the body has aninferior face and wherein an attachment face extends downwardly from theinferior face.
 3. The screw guide assembly according to claim 2, whereinthe body has a superior face opposite the inferior face, and wherein thescrew guide assembly further comprises a handle rotatably attachable tothe proximal end portion.
 4. The screw guide assembly according to claim3, wherein the the attachment face extends perpendicular to thelongitudinal axis.
 5. The screw guide assembly according to claim 4,wherein when the handle is attached to the proximal end portion, thehandle extends co-linearly with the attachment face.
 6. The screw guideassembly according to claim 4, wherein the attachment face is configuredto releasably connect to an implant.
 7. The screw guide assemblyaccording to claim 1, wherein the body comprises a central portionbetween the proximal end portion and the distal end portion, wherein thecentral portion has at least one through-opening extending therethrough.8. The screw guide assembly according to claim 1, wherein the screwsupport member comprises a screw through-opening extending therethrough.9. The screw guide assembly according to claim 8, wherein the screwthrough-opening extends obliquely to the longitudinal axis.
 10. A screwguide assembly comprising: a guide body extending along a centrallongitudinal axis, the guide body having: a proximal end portion; and adistal end portion having an outrigger, the outrigger having a screwsupport member extending away from the longitudinal axis, the screwsupport member having a through opening configured to allow for theinsertion of a screw at an angle oblique relative to the longitudinalaxis; and the outrigger having a first arm extending from a first end ofthe outrigger on a first side of the through opening and a second armextending from a second end of the outrigger on a second side of thethrough opening, wherein the first arm comprises a first portionextending obliquely from the distal end portion and a second portionextending generally orthogonally to the distal end portion.
 11. Thescrew guide assembly according to claim 10, wherein the guide bodyextends in a first plane and the second portion extends in a secondplane, different from the first plane.
 12. A screw guide assemblycomprising: an elongate body having: a proximal end portion adapted toreleasably connect to an implant, the proximal end portion having aproximal through opening extending therethrough; and a distal endportion, distal from the proximal end portion; a longitudinal axisextending through the proximal end portion and the distal end portion,the body having a plurality of axis through openings extendingco-linearly along the longitudinal axis; an outrigger extending from thedistal end portion and having a screw through-opening extendingtherethrough, the screw through-opening extending obliquely relative tothe longitudinal axis; a first arm having a first end attached to thedistal end portion and a second end attached to the outrigger on a firstside of the screw through-opening; and a second arm having a first endattached to the distal end portion and a second end attached to theoutrigger on a second side of the screw through-opening, across from thefirst side of the screw through opening.
 13. The screw guide assemblyaccording to claim 12, wherein the proximal end portion comprises ahandle extending upwardly therefrom.
 14. The screw guide assemblyaccording to claim 12, wherein the body further comprises a centralportion connecting the proximal end portion and the distal end portion,wherein the central portion comprises at least one centralthrough-opening extending therethrough.
 15. The screw guide assemblyaccording to claim 12, further comprising an attachment face attached tothe proximal end rtior, the attachment face configured to releasablyconnect to the implant.
 16. The screw guide assembly according to claim15, wherein the attachment face extends perpendicularly to the body. 17.The screw guide assembly according to claim 12, wherein the screwthrough-opening extends at an angle between about 20 degrees and about30 degrees relative to the body.
 18. The screw guide assembly accordingto claim 12, wherein the first arm has a first portion extendingobliquely from the distal end portion and a second portion extendinggenerally orthogonally to the distal end portion.